DOR/ISL for HIV/AIDS

Recruiting at 96 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Doravirine/Islatravir

Disqualifiers: HIV-1 RNA ≥200 copies/mL, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 96 weeks

650 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to check if the combination of DOR and ISL is safe and well-tolerated in adults with HIV-1 who have used these drugs before. The study focuses on ensuring that the treatment does not cause harmful side effects in these patients.

Will I have to stop taking my current medications?

The trial requires participants to already be taking the DOR/ISL medication from previous studies, so you will need to continue with this medication. The protocol does not specify if you need to stop other medications.

Is DOR/ISL safe for humans?

The available research does not specifically mention DOR/ISL, but it highlights that antiretroviral drugs, in general, can cause adverse drug reactions (side effects) in people with HIV. These reactions are often not serious, but they can lead to stopping the medication in some cases. It's important to monitor for side effects when taking any antiretroviral therapy. ^{1 2 3 4 5}

What makes the drug DOR/ISL unique for treating HIV/AIDS?

DOR/ISL is a novel two-drug regimen that combines doravirine and islatravir, offering a potentially simpler treatment option compared to traditional three-drug regimens. This approach aims to reduce long-term side effects, costs, and improve convenience for patients by using fewer drugs while maintaining effective control of the virus. ^{6 7 8 9 10}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with HIV-1 who were previously treated with DOR/ISL in certain Merck Sharp & Dohme clinical studies. It's not open to those who are heavily treatment-experienced from other trials.

Inclusion Criteria

I am currently in a clinical study for DOR/ISL by MSD.

Exclusion Criteria

My HIV-1 RNA level is 200 copies/mL or higher.

Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL

Is a HTE participant receiving treatment in MK-8591A-019 or -033

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DOR/ISL (100 mg/0.25 mg) once daily from Day 1 to Week 96

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Open-label extension

Eligible participants may continue on DOR/ISL until Week 240 or until DOR/ISL becomes commercially accessible

Up to 144 weeks

Treatment Details

Interventions

• DOR/ISL

Trial Overview The study is testing the safety and how well people tolerate a combination HIV drug called Doravirine/Islatravir (DOR/ISL). There's no specific hypothesis being tested; it's more about ongoing observation of participants' reactions to the drug.

Participant Groups

Group I: DOR/ISL Experimental Treatment 1 Intervention

Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken once daily (QD) orally from Day 1 to Week 96. After Week 96, eligible participants may continue on DOR/ISL until week 240 or until DOR/ISL becomes commercially accessible, whichever comes first.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

Between 1999 and 2003, a study at Toulouse University Hospital reported 613 adverse drug reactions (ADRs) from antiretroviral drugs affecting 428 patients, highlighting the importance of monitoring these effects.

Most reported ADRs (88.6%) were classified as 'non-serious', but 57% of cases required stopping the suspected medication, indicating that while many reactions were mild, a significant portion still necessitated intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Bandrant, M., Bagheri, H., Cuzin, L., et al.[2016]

In a study of 844 adult HIV patients in Mali, 42.3% experienced adverse drug reactions (ADRs) after starting antiretroviral therapy, with neurological issues being the most common (45.9%).

Zidovudine (AZT) and stavudine (d4T) were identified as significant risk factors for anemia and peripheral neuropathy, emphasizing the need for careful monitoring and potential changes in ART regimens to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiretroviral-induced adverse drug reactions in HIV-infected patients in Mali: a resource-limited setting experience. Oumar, AA., Dakouo, M., Tchibozo, A., et al.[2022]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Characteristics of adverse event reports among people living with human immunodeficiency virus (HIV) in Japan: Data mining of the Japanese Adverse Drug Event Report database. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and antiretroviral effects of combined didanosine and stavudine therapy in HIV-infected individuals with CD4 counts of 200 to 500 cells/mm3. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Prevalence and factors associated with adverse drug events among patients on dolutegravir-based regimen at the Immune Suppression Syndrome Clinic of Mbarara Regional Referral Hospital, Uganda: a mixed design study. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[Not Available]. [2016]

5. India pubmed.ncbi.nlm.nih.gov

Antiretroviral-induced adverse drug reactions in HIV-infected patients in Mali: a resource-limited setting experience. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Switching to Dolutegravir/Lamivudine in Virologically Suppressed People Living with HIV-1 Aged Over 65 Years. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Similar CD4/CD8 Ratio Recovery After Initiation of Dolutegravir Plus Lamivudine Versus Dolutegravir or Bictegravir-Based Three-Drug Regimens in Naive Adults With HIV. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Risks and benefits of reducing the number of drugs to treat HIV-1 infection. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

Executive summary of the GESIDA/National AIDS Plan Consensus Document on Antiretroviral Therapy in Adults Infected by the Human Immunodeficiency Virus (Updated January 2016). [2018]

10. England pubmed.ncbi.nlm.nih.gov

Factors associated with the use and composition of two-drug regimens in a large single-centre HIV cohort. [2021]